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FDA新药信息
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Ionsys Iontophoretic Transdermal System Generic Name: fentanyl Date of Approval: May 23, 2006 Company: ALZA Corporation Treatment for: Acute Postoperative Pain -------------------------------------------------------------------------------- The US Food and Drug Administration (FDA) has approved Ionsys (fentanyl iontophoretic transdermal system), the first needle-free, patient-activated analgesic system. Ionsys is indicated for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia during hospitalization. Ionsys is the first and only product to incorporate the proprietary E-TRANS(R) iontophoretic transdermal drug delivery system developed by ALZA. E-TRANS utilizes iontophoresis -- a process in which a low-intensity electric field, which is generally imperceptible to the patient, is used to rapidly transport fentanyl across the skin and into the circulatory system of the body. Ionsys securely adheres to the upper outer arm or chest, and provides patients an on-demand dose of fentanyl. Fentanyl is an opioid analgesic that has been used in the management of pain for more than 40 years. Ionsys is indicated for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia during hospitalization. Patients should be titrated to an acceptable level of analgesia before initiating treatment with Ionsys. Ionsys is not intended for home use and is, therefore, inappropriate for use in patients once they have been discharged from the hospital. It is not recommended for patients under the age of 18 years (see WARNINGS and PRECAUTIONS section of the full prescribing information). Unlike other methods of administering pain medications after surgery such as intravenous patient-controlled analgesia (IV PCA) pumps, which tether patients to an IV pole and equipment, Ionsys is compact, self-contained and needle-free. When pain medication is needed, the patient double-clicks the dosing button, which delivers a pre-programmed, 40mcg dose of fentanyl through the skin. Each dose is delivered over a 10-minute period. Patients should be titrated to comfort before initiating Ionsys. Ionsys should be applied to intact, non-irritated and non-irradiated skin on the chest or upper outer arm. Patients must have access to supplemental analgesia. Important Safety Information Ionsys should only be used for the treatment of hospitalized patients. Treatment with Ionsys should be discontinued before patients are discharged from the hospital. Treatment with fentanyl, the active component of Ionsys, may result in potentially life-threatening respiratory depression and death. To avoid potential overdosing, only the patient should activate Ionsys dosing. Inappropriate use of Ionsys leading to ingestion or contact with mucous membranes or unintended exposure to the fentanyl hydrogel could lead to the absorption of a potentially fatal dose of fentanyl. Therefore, the hydrogels should not come into contact with the fingers or mouth. Ionsys contains fentanyl, a potent opioid agonist and a Schedule II controlled substance with high potential for abuse similar to hydromorphone, methadone, morphine and oxycodone. Fentanyl can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Ionsys in situations where the Health Care Professional is concerned about an increased risk of misuse, abuse or diversion. After the maximum dosage administration, a significant amount of fentanyl remains in the device. Ionsys should always be kept out of reach of children. Ionsys is contraindicated in patients with known hypersensitivity to fentanyl, cetylpyridinium chloride, (e.g. Cepacol) or any components of the Ionsys system. Ionsys should be prescribed only by persons knowledgeable in the administration of potent opioids, and in the management of patients receiving potent opioids for treatment of pain. Patients treated with Ionsys should be under the supervision of medical personnel with expertise in the detection and management of hypoventilation, including airway management and the use of opioid antagonists. Since serum fentanyl concentrations decline gradually after system removal, patients who have experienced serious adverse events, including overdose, will require continued monitoring after removal of Ionsys. To avoid potential overdosing, only the patient should activate Ionsys. More than one Ionsys system should not be applied to a patient at the same time. If the fentanyl hydrogel becomes separated from the Ionsys system, contact can be harmful to humans and animals. If this happens during system removal use gloves or tweezers to remove the hydrogel from the skin and properly dispose of in accordance with state and federal regulations for controlled substances. The skin area that had been in contact with the hydrogel should be thoroughly flushed with water. Do not use soap, alcohol or other solvents to remove the hydrogel as they may enhance the drug's ability to penetrate the skin. In the event that the Ionsys system falls off, ensure that the entire Ionsys system (i.e. with hydrogel) is collected and properly disposed of. Prior to discharge from the hospital, medical personnel must remove the Ionsys system and dispose of it properly (see DOSAGE AND ADMINISTRATION, Disposal section of the full prescribing information). The most common (greater than 10%) adverse events reported in 2,114 patients treated with Ionsys 40mcg/dose including 3 Placebo-Controlled Trials and 4 Active Comparator Trials vs. IV PCA morphine, regardless of relationship to study medication, were nausea, vomiting, application site reaction- erythema, fever and headache. |
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2楼2006-06-03 15:44:43
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Xyotax Cell Therapeutics, Inc. (CTI) and FDA Agree on NDA Filing Strategy for Xyotax PIONEER Trial Interim Data to Provide Basis for Review Supported by Gender-Specific STELLAR Trial Results SEATTLE, June 01, 2006 -- Cell Therapeutics, Inc. (CTI) announced that at a recent meeting with the U.S. Food and Drug Administration (FDA), CTI and the FDA agreed on a new drug application (NDA) route for Xyotax (paclitaxel poliglumex) for women with lung cancer. The FDA agreed to review an NDA submission based on interim results of the PIONEER trial with the results of the STELLAR 3 and 4 trials to support the filing. Based on this feedback, if the PIONEER trial meets its pre-specified interim endpoint, CTI plans to submit an NDA in the first half of 2007 and would request a priority (six month) review based on the fast track designation, instead of the standard (ten month) review as previously planned. "We are happy with the outcome from our pre-NDA meeting with the FDA, which focused on how best to utilize the survival data observed among women in the STELLAR 3 and 4 trials and confirmatory data from our ongoing gender- specific PIONEER trial," stated James A. Bianco, M.D., President and CEO of CTI. "By reviewing an NDA based on interim data from the PIONEER study, this approach could reduce the approval process for this novel therapeutic by more than 12 months over a filing based on full results of the PIONEER study." "Lung cancer is a major unmet medical crisis for women and will kill 70,000 women this year. The biology of lung cancer is different in women and they appear to respond differently to treatment than men. We need to examine the potential for gender-specific therapy, not only in lung cancer but in a number of cancers that are known to express the estrogen receptor. Increasing knowledge of human biology is the ultimate promise of personalized medicine," Bianco added. About the PIONEER clinical trial The PIONEER clinical trial is targeting approximately 170 sites in the United States, Eastern Europe, and Latin America. CTI expects to enroll approximately 600 PS2 chemotherapy-naive women with advanced stage NSCLC. Each study arm of approximately 300 patients will be randomized to receive either Xyotax (at a dose of 175mg/m(2) paclitaxel equivalents) or paclitaxel (at a dose of 175mg/m(2)) once every three weeks. The primary endpoint is superior overall survival with several secondary endpoints including disease control, response rate in patients with measurable disease, time to disease progression, and disease-related symptoms. About Xyotax Xyotax (paclitaxel poliglumex) is a biologically-enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. Based on preclinical studies, it appears that Xyotax is preferentially trapped in the tumor blood vessels allowing significantly more of the dose of chemotherapy to localize in the tumor. Preclinical and clinical studies support that Xyotax metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies. |
3楼2006-06-03 20:13:52
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4楼2006-06-04 09:36:24